Inspectors have found violations of good manufacturing practice regulations
of ConsumerAffairs
Pain Relief Naturally of Salem, Ore., is recalling all lots ofExtra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, Extra Strength PreTAT by TAT Balm Carbomer Free Gel and Naturally HL Bedsore Relief Cream.
A Food and Drug Administration inspection found significant violations of current good manufacturing practice regulations.
This represents the possibility of risk being introduced into the manufacturing process in decreased quality and consistency (i.e., the safety, identity, strength, quality and purity).
The firm has received reports of subpotency in Extra Strength PreTAT by TAT Balm Carbomer Free Gel
The following products are being recalled:
| Product | Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine |
|---|---|
| Lots Recalled | All lots sold before 10/17/2017 |
| Expiration Dates | All products expiring before 10/17/2018 |
| NDC #'s | 68904-014, 69804-015, 69804-024 |
| Use | For temporary relief of pain and itching |
| Container Type | Black jars and bottle |
| Sizes | 1/2 ounce, 1 ounce, 2 ounce and 4 ounce |
| Strenght | 4% |
| Product | Extra Strength Naturally HL Bedsore Relief Cream With Lidocaine |
|---|---|
| Lots Recalled | All lots sold before 10/17/2017 |
| Expiration Dates | All products expiring before 10/17/2018 |
| NDC #'s | 69804-008 |
| Use | For temporary relief of pain and itching |
| Container Type | Black jars and bottle |
| Sizes | 1/2 ounce, 1 ounce, 2 ounce and 4 ounce |
| Strenght | 4% |
| Product | Extra Strength PreTAT by TAT Balm Carbomer Free GelWith Lidocaine |
|---|---|
| Lots Recalled | All lots sold before 10/17/2017 |
| Expiration Dates | All products expiring before 10/17/2018 |
| NDC #'s | 69804-018 |
| Use | For temporary relief of pain and itching |
| Container Type | Black jars and bottle |
| Sizes | 1/2 ounce, 1 ounce, 2 ounce and 4 ounce |
| Strenght | 4% |
The recalled products were sold nationwide via the internet at amazon.com, ebay.com, naturallyhl.com, and tatbalm.net.
What to do
Customers who purchased the recalled products should stop using them, discard them, or return them to:
Pain Relief Naturally
ATTN RECALL
4995 Ridge Dr NE
Salem, OR, 97301
Consumers with questions may contact the firm at 877-906-4806 Monday Friday, 9am 5pm (PST) or by email at PRNCustomerCare@Gmail.com.